Manage Every Link in the Chain with Axway ePedigree

In Life Sciences industries, branded pharmaceutical, biotech and speciality drug manufacturers are prime targets of counterfeiters. The World Health Organisation (WHO) estimates that $32 billion in legitimate business sales are lost each year due to the sale of counterfeit drugs, and that this figure will reach $75 billion by 2010.

To improve the safety and integrity of the global supply chain, the American Food & Drug Administration (FDA), individual American states including California and Florida, the E.U. and Turkey are planning to establish stringent, pedigree regulations in the coming months. These anti-counterfeiting regulations will require pharmaceutical supply chain constituents to provide drug pedigrees, or custodial histories, which trace each drug’s chain of ownership from the pharmacy back to the manufacturer.

Axway Track & Trace and ePedigree are GS1 standards-based, anti-counterfeiting solutions that centrally manage regulatory requirements to reduce the cost and complexity of compliance with pedigree laws.

Track & Trace manages serialised and non-serialised product events in an open framework, to allow internal and external trusted parties to access product identification, location, pedigree and event data at any point in the supply chain.

Fully integrated with Track & Trace, Axway’s ePedigree guarantees the authenticity of origin and demonstrates possession as pharmaceutical drugs move through the supply chain, providing a clear trail of ownership at each step in the process.

ePedigree provides:

• Complete visibility into the custodial history of drugs or batches of drugs,
• Comprehensive archiving, reporting and alerting for regulatory compliance and exception management,
• Continuous alignment with changing Electronic Product Code (EPC) and RFID standards,
• 21 CFR Part 11 compliance for electronic records and digital signatures.

Track & Trace and ePedigree allow you to link physical inventory movements to B2B transactions, such as purchase orders, shipping notices and invoices. This linkage provides greater business activity monitoring of your supply chain and helps you achieve sustainable business value from what might normally be considered a cost of compliance.

Most importantly, all members of the supply chain can leverage existing investments in supply chain automation, serialisation and company systems, to increase the speed and quality of shipping and receiving, accelerate returns processing and improve recall accuracy.

Manufacturers can use ePedigree to:

• Create and send electronic pedigrees,
• Store and access electronic pedigrees,
• Validate electronic pedigrees for returns processing.

Wholesalers can use ePedigree to:

• Validate electronic pedigrees,
• Correlate electronic pedigrees to physical inventory,
• Create and send electronic pedigrees as inventory is split,
• Store and access electronic pedigrees.

Retailers can use ePedigree to:

• Validate electronic pedigrees prior to dispensing drugs,
• Correlate electronic pedigrees to physical inventory,
• Create and send electronic pedigrees for returns processing,
• Store and access electronic pedigrees.